Defitelio

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

defibrotide

Available from:

Gentium S.r.l.

ATC code:

B01AX01

INN (International Name):

defibrotide

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Hepatic Veno-Occlusive Disease

Therapeutic indications:

Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.It is indicated in adults and in adolescents, children and infants over 1 month of age.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2013-10-18

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFITELIO 80 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
defibrotide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor.
−
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Defitelio is and what it is used for
2.
What you need to know before you are administered Defitelio
3.
How you will be given Defitelio
4.
Possible side effects
5.
How to store Defitelio
6.
Contents of the pack and other information
1.
WHAT DEFITELIO IS AND WHAT IT IS USED FOR
Defitelio is a medicine that contains the active substance
defibrotide.
It is used to treat a condition called hepatic veno-occlusive disease,
in which the blood vessels in the
liver become damaged and obstructed by blood clots. This can be caused
by medicines that are given
prior to a stem cell transplantation.
Defibrotide works by protecting the cells of the blood vessels and
preventing or breaking down the
blood clots.
This medicine can be used in adults, and in adolescents, children and
infants over one month of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED DEFITELIO
DO NOT USE DEFITELIO
•
if you are allergic to defibrotide or any of the other ingredients of
this medicine (listed in
section 6)
•
if you are using other medicines to break down blood clots such as
tissue plasminogen activator.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Defitelio:
•
if you are taking medicine that increases the risk of bleeding.
•
if you have heavy bleeding and need a bloo

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Defitelio 80 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of concentrate contains defibrotide* 80 mg corresponding to a
quantity of 200 mg in 2.5 mL
in a vial, and corresponding to a concentration in the range of 4
mg/mL to 20 mg/mL after dilution.
* produced from porcine intestinal mucosa.
Excipient with known effect
Each vial contains 0.89 mmol (equivalent to 20.4 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The solution is clear light yellow to brown, free from particulate
matter or turbidity.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Defitelio is indicated for the treatment of severe hepatic
veno-occlusive disease (VOD) also known as
sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell
transplantation (HSCT) therapy.
It is indicated in adults and in adolescents, children and infants
over 1 month of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Defitelio must be prescribed and administered to patients by
specialised physicians experienced in the
diagnosis and treatment of complications of HSCT.
Posology
The recommended dose is 6.25 mg/kg body weight every 6 hours (25
mg/kg/day).
There is limited efficacy and safety data on doses above this level
and consequently it is not
recommended to increase the dose above 25 mg/kg/day.
The treatment should be administered for a minimum of 21 days and
continued until the symptoms
and signs of severe VOD resolve.
3
_Renal impairment _
Dose adjustment is not required for patients with renal impairment or
who are on intermittent
haemodialysis (see section 5.2).
_Hepatic impair